510(k) DEN150053

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

July 27, 2017

Date Received

November 18, 2015

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Fetal Head Elevator

Device Class

Class II

Regulation Number

884.4350

Review Panel

OB

Submission Type

To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery.